WALLFLEX DUODENAL M00565020 6502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-01 for WALLFLEX DUODENAL M00565020 6502 manufactured by Boston Scientific Corporation.

Event Text Entries

[134748984] (b)(4). The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[134748985] It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex doudenal stent has been implanted to treat a malignant gastric outlet obstruction in the duodenum during a stent placement procedure performed on (b)(6) 2019. Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement. According to the complainant, during the procedure, the stent was fully deployed. However, after deployment the physician had concerns that the stent did not fully expand. Reportedly, the stent left implanted and the physician did not take any action to expand the stent. The stent was not removed and it was reported that the stent has since fully expanded. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-00265
MDR Report Key8297145
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-02-01
Date of Report2019-02-01
Date of Event2019-01-07
Date Mfgr Received2019-01-07
Device Manufacturer Date2018-09-26
Date Added to Maude2019-02-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1BOSTON SCIENTIFIC IRELAND LIMITED
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWALLFLEX DUODENAL
Generic NameSTENT,METALLIC,EXPANDABLE,DUODENAL
Product CodeMUM
Date Received2019-02-01
Model NumberM00565020
Catalog Number6502
Lot Number0022708562
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-01

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